This study is a phase III study of SHR-1905 in subjects with severe uncontrolled asthma. The purpose of the study is to evaluate efficacy and safety of SHR-1905 in subjects with severe uncontrolled asthma.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
408
SHR-1905 injection.
SHR-1905 placebo Injection.
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
RECRUITINGAnnual asthma exacerbation rate
Time frame: During 48 weeks of treatment.
Mean change from baseline in pre-dose/pre-bronchodilator (Pre-BD) forced expiratory volume in 1 Second (FEV1)
Time frame: At Week 48.
Proportion of participants who had asthma exacerbations
Time frame: From randomization to Week 48.
Time to the first asthma exacerbation
Time frame: From randomization to Week 48.
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